1. Field of the Invention
The present invention generally relates to flanged, generally tubular articles, including bidirectionally donnable multiple flange condom articles, and to method and apparatus for making and using such articles.
2. Description of the Related Art
In recent years, there has been a significant increase in the incidence and spread of sexually transmitted diseases, and this phenomenon has in turn caused an increased use of condoms as a prophylactic measure to reduce the risk of infection and transmission of such diseases.
Among the reasons for the increase in incidence and rate of transmission of sexually transmitted diseases (STDs) are the development of increasingly antibiotic-resistant strains of disease-causing organisms, e.g., those responsible for diseases such as syphilis and gonorrhea. Another factor has been the absence of any effective cure for acquired immunodeficiency syndrome (AIDS).
Against the foregoing background, and the recognition that condoms afford a safe, low cost, and generally reliable means for combatting the spread of STDs including AIDS, there has been an increased demand for condoms.
Currently, most condoms are produced from a latex resin via a dipping process in which a cylindrical and rounded-end mold is dipped into a resin bath, so that the mold is coated with a thin layer of the latex material. The thickness of the latex coating on the mold is dependent on the viscosity of the latex, and the speed of extracting the mold from the latex bath. Similar latex dipping processes have been employed with suitably shaped molds to form tight-fitting gloves such as surgical gloves.
The above-described latex dipping process has been utilized for decades, and yields a generally satisfactory barrier product at reasonable cost.
With the recent spread of AIDS in the general population and the resurgence of condom usage in sexual activities, there has been interest in improving the strength and reliability characteristics of condoms, and of achieving improvements in manufacturing processes and economics, to further combat the spread of STDs generally, and AIDS specifically, as well as to provide a safe, reliable, and convenient contraceptive means. In this respect, there is a continuing need to provide condoms in a readily packaged form. The packaging itself should ensure the physical integrity, safety, and effectiveness of the condom are maintained. The package and the condom should be designed in a manner facilitating ready removal and use of the condom, in order to enhance the appeal of using condoms in coital activity.
U.S. Pat. No. 4,576,156, issued Mar. 18, 1986 to Manfred F. Dyke, discloses a condom formed of a thermoplastic polyurethane material, having a generally cylindrical configuration with an open proximal end and a closed distal end. The disclosed condom has a thickness of from about 0.01 millimeters, or less, to about 0.25 millimeters. The thermoplastic polyurethane employed to form the condom is disclosed as having: an average Shore A hardness of from about 50 to about 90; a tensile stress, at 100% of elongation, between about 300 and 1,000 psi; and a tensile stress, at 300% elongation, between about 800 and 3,000 psi. Suitable thermoplastic polyurethane species for manufacturing the condom include those set out at column 2, line 55 to column 3, line 10 of the Dyke patent, with polyether- or polyester-based urethane elastomer said to be preferred. In the manufacture of the thermoplastic polyurethane condom disclosed in the Dyke patent, a film of the polyurethane material, e.g., in the form of a 6-inch square, is heated to a temperature high enough to soften the polymer but low enough to avoid chemical degradation, preferably in a clamping frame, and at a temperature of about 400.degree.-500.degree. F. The heated film then is brought into contact with a preformed mandril to cause the film to assume the shape of the mandril, preferably with application of a vacuum to the system in order to bring about uniformity in wall thickness (column 3, lines 47-50 of the patent).
European patent application 0 147 072, published Jul. 3, 1985, in the names of Robert A. Taller, et al, discloses a process for making a polyurethane condom with a uniform thickness of from about 1.5 to about 4 mils. A heat-curable polyurethane prepolymer solution is employed into which a mold is dipped and withdrawn for heat curing on the mold. The polyurethane prepolymer which is employed in the dipping medium is the reaction product of a polyisocyanate and with at least one long chain polyol. The polyol is amorphous at room temperature, has an average molecular weight of from about 500 to about 5,000, and a hydroxyl number of from 225 to about 22.4. The polyurethane prepolymer has a NCO/OH ratio of from about 0.95:1 to about 1.1:1.
U.S. Pat. No. 4,009,717 to C. H. Allen discloses a condom comprising inner and outer sheaths, with the inner-sheath volume providing a fluid reservoir so that the interior of the inner sheath remains dry. The outer sheath is closed at one end and open at the other. The inner sheath is open at both ends inside the outer sheath, with means between the inner and outer sheath establishing a fluid-tight seal to form the fluid reservoir therebetween.
U.S. Pat. No. 4,955,392 to R. Sorokin discloses a condom formed of elastomeric film material and including a tubular length having a closed distal end and a proximal open end with an integral pubic shield about the proximal open end.
U.S. Pat. No. 4,232,675 to E. N. Meldahl discloses a modified condom of shorter length than conventionally employed, interiorly containing a spermicidal ring and a penis-supported harness assembly.
Various condom designs have evolved which feature a double-walled chamber at the distal end of the condom containing contraceptive or medicant material. Examples include U.S. Pat. No. 4,332,243 to M. Gutnick; U.S. Pat. No. 2,410,460 to J. P. Robinson; U.S. Pat. No. 4,446,860 to M. Gutnick; and U.S. Pat. No. 2,577,345 to F. L. McEwen.
West German Offenlegungsschrift 2020280 discloses a condom comprising two sheaths inserted in each other, the inner sheath having an opening through which semen can discharge and be fastened in place by two rubber rings.
U.S. Pat. No. 2,433,538 to H. W. Warner discloses a semen receptacle article having a removable container therein. The container has a distal receiver opening and contains absorbent material for receiving and absorbing a sperm specimen. It appears from the description that the receptacle member is placed on the male organ with the distal end of the penis in the vicinity of the proximal wall of the sperm container, but not inserted through the sperm container opening.
U.S. Pat. No. 2,586,674 to F. Lonne describes a prophylactic construction (see FIG. 3 of the patent, and appertaining description at column 2, lines 26-36) wherein a double-layer condom comprises an inner pellicle having annular projections or extensions transverse to the longitudinal dimension of the prophylactic.
U.S. Pat. No. Design 253,009 to T. Okamoto shows a prophylactic device whose frontal (distal) section comprises a pair of indented surface portions forming circumferential grooves in the prophylactic, transverse to the longitudinal axis thereof.
U.S. Pat. No. 3,295,145, to R. E. Erickson describes a urine collector for infants, comprising front and rear panels sealed to one another to form a throat dividing the collector into upper and lower compartments. The back panel of the collector features an oval aperture surrounded by a pressure-sensitive adhesive for adhering the collector to the infant's skin. The collector panels preferably are formed of a substantially transparent thermoplastic film such as polyethylene, vinyl copolymers and the like, at a thickness of from about 0.5 to 3 mils.
U.S. Pat. No. 4,022,213, to D. Stein discloses a male drip urinal comprising a tubular sleeve including a thin rubber sheath which is stretched over the penis for sealing purposes. An apertured resilient sheet extends across the mouth of the urinal sleeve for sealing about the base of the penis, to provide a backup seal should the inner sheath tear. The sheet is carried by an annular ring forming the mouth of the urinal sleeve.
U.S. Pat. No. 2,448,938, to A. Wayne describes a sanitary protective appliance which may be configured with a shield-like body portion of slightly convex shape in side elevation view, with an accordion-like finger portion which is foldable back against the convex face of the body portion. The finger portion is convergingly shaped from its proximal to its distal end portions. The body portion of this device contains a generally central opening forming a passage into the finger portion and comprises an integral tab to facilitate removal of the appliance after use. The rear (proximal) face of the body portion is peripherally coated with an adhesive coating material, except for the tab. The adhesive coating is overlaid with a gauze cover which is removable to affix the appliance, for covering or protecting a body appendage.
U.S. Pat. No. 4,735,621, to L. Hessel discloses a tubular protective condom-like device comprising a flexible, thin-walled tube closed at one end and having its opposite open end a collar-shaped, outwardly extending portion with means for radially stretching the collar or open end. In one disclosed embodiment, the device has a first outwardly extending ring-shaped means adapted for radially extending the open end, and a second outwardly extending ring-shaped means adapted for radially extending the open end, and a second outwardly extending ring-shaped means that is adapted for radially extending the closed end. The second ring-shape means thus secures or maintains the device in the vagina in a manner similar to a diaphragm.
U.S. Pat. No. 4,964,416 to Robert G. Wheeler discloses a condom having a main sheath portion closed at a distal end and open at a proximal end thereof, which may be constructed from thermoplastic elastomeric materials. The condom also has an annular-shaped sealing element, formed of an elastic material, circumscribing an interior opening of smaller size than the proximal end opening of the condom, and joined at the outer periphery of the sealing element to the main sheath, at or in the vicinity of the proximal end opening. Such construction thereby provides a barrier member in the proximal segment of the condom to enhance its effectiveness as a contraceptive and to minimize the incidence of sexually transmitted diseases.
U.S. Pat. No. 4,834,113 to A. V. K. Reddy discloses a prophylactic device to be worn by a recipient coital party, which utilizes a rolled-up pouch portion as a body cavity entry guide. As such the device can only be oriented upon the wearer's body in one direction for proper use.
U.S. Pat. No. 4,415,548 to A. V. K. Reddy discloses a spermicidally-active lubricated prophylactic, having a spermicidally active lubricant on both sides of the condom.
There are, however, several deficiencies which still need to be addressed and which would provide a major improvement in condom articles. These include: air entrapment caused by donning an unfurled (i.e., non-rolled, such as a natural skin) condom: the friction or "drag" associated with donning an unfurled condom; acceptable, comfortable aperture size; the necessity of having the correct side of previously rolled or slip-on condoms contact the penis, in order for donning to be successful; and the need for greater ease of handling the condom while donning.
In respect of the "correct side" deficiency noted above, this characteristic is particularly applicable to rolled condoms which are "rolled up" along the entire length of the sheath to yield a fully rolled product of generally flat configuration in which the distal end portion of the sheath is surrounded by a toroidal ring constituted by the rolled sheath material. When such rolled condom is removed from its package, particularly in a low-light or dark environment, it frequently occurs that the condom is applied to the tip of the glans in a "wrong facing" orientation, such that it is not able to be unrolled on the penis by manually urging the roll downwardly over the shaft of the penis. The user, upon discerning such wrong orientation, then flips the rolled condom over and properly applies it to the penis, but in such process, the surface of the condom film initially contacting the glans is externally exposed on the condom as finally installed. This may result in transmission of sexually transmittable disease and/or sperm to the recipient coital partner, whereby the contraceptive and disease-protective functions of the condom are compromised.
Even in a fully illuminated environment, inexperienced condom users frequently initially position rolled condoms on the penis in a "wrong side up" orientation.
Accordingly, it is an object of the present invention to provide improved flanged tubular articles, e.g., condoms, which are readily, simply, and inexpensively formed.
It is another object of the present invention to provide improved condom articles which substantially eliminate air entrapment, reduce friction associated with donning of the condom article, eliminate the "one right side" feature of previous condoms, and provide simpler handling and greater ease of use, as compared to conventional condoms.
A further object of the present invention is to provide an acceptable, comfortable aperture size in the condom article, which is absent in prior art flanged condom articles.
It is another object of the invention to provide apparatus and methods for making and using condoms of the aforementioned type.
Other objects and advantages of the present invention will be more fully apparent from the ensuing disclosure and appended claims.